1.1这些规范和测试方法旨在为脊柱-骨骼系统手术固定中使用的系统组件提供全面的参考。该文件对指定材料、标签和处理要求的标准规范进行了分类。规范和测试方法还建立了通用术语，可用于描述脊柱组件的尺寸和其他物理特征，以及与脊柱组件性能相关的性能定义。 此外，规范和测试方法制定了性能要求和标准测试方法，以一致地测量脊柱组件的性能相关机械特性。 1.2这些规范和测试方法是一系列标准，可用于解决与脊柱-骨骼系统手术固定系统相关的问题。这些规范和测试方法集中于在许多脊柱固定系统中发现的单个组件。 如果用户有兴趣评估脊柱固定系统链的下一个层次，即单个组件和子组件（两个或多个组件）之间的互连，用户应参考指南F 1798。该链的最高层次是测试方法F 1717，该方法用于评估由许多组件组装而成的整个结构，并涉及许多互连和几个子组件。 1.3这些规范和测试方法的目的不是定义性能或情况的水平- 本文件所述脊柱组件的具体临床表现。没有足够的知识来预测在个别患者的日常生活活动中使用这些成分的后果。此外，本文件无意描述或指定用于脊柱-骨骼系统手术内固定的系统单个组件的具体设计。 1.4这些规范和测试方法可能不适用于所有类型的脊柱手术固定系统。 鉴于特定植入系统及其潜在应用，用户应谨慎考虑本文件的适当性。 1.5本文件包括用于确定脊柱组件机械性能特征的以下规范和测试方法: 1.5.1金属脊柱螺钉规范附录A1。 1.5.2金属脊柱板规范附录A2。 1.5.3金属脊柱杆规范附录A3。 1.5.4测量金属脊柱螺钉静态和疲劳弯曲强度的试验方法附录A4。 1.6除非另有说明，否则以国际单位制表示的数值应视为标准。 1.7本标准可能涉及危险材料、操作和设备。 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。

1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. 1.2 These specifications and test methods are a series of standards available for addressing the concerns related to systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F 1798. At the highest level in this chain is Test Methods F 1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies. 1.3 It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components addressed by this document. Insufficient knowledge is available to predict the consequences of using any of these components in individual patients for specific activities of daily living. Furthermore, it is not the intention of this document to describe or specify specific designs for the individual components of systems used in the surgical internal fixation of the spinal skeletal system. 1.4 These specifications and test methods may not be appropriate for all types of spinal surgical fixation systems. The user is cautioned to consider the appropriateness of this document in view of the particular implant system and its potential application. 1.5 This document includes the following specifications and test methods that are used in determining the spinal component's mechanical performance characteristics: 1.5.1 Specification for Metallic Spinal Screws—Annex A1. 1.5.2 Specification for Metallic Spinal Plates—Annex A2. 1.5.3 Specification for Metallic Spinal Rods—Annex A3. 1.5.4 Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal Screws—Annex A4. 1.6 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard. 1.7 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.